The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection

NCT ID: NCT03273231

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-07-31

Brief Summary

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Systemic inflammation caused by surgery may aggravate immunosuppression in immunocompromised cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity. ketamine, a N-methyl-D-asparate receptor antangonist, has anti-inflammatory activity and opioid-sparing effect. This study investigate the effect of intraopertaive ketamine administration on immune function in patients undergoing laparoscopic colorectal cancer resection.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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ketamine group

Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery.

control group

0.9% saline solution

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

0.9% saline solution

Interventions

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Ketamine

Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery.

Intervention Type DRUG

Saline

0.9% saline solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patient between 20 and 80 of age with ASA physical status Ⅰ-Ⅲ
* patient scheduled for laparoscopic colorectal cancer resection

Exclusion Criteria

* ASA physical status Ⅳ
* severe hepatorenal disease
* heart failure
* infection
* increased intracranial pressure, seizure
* preoperative chemotherapy
* immune or endocrine disease
* metastasis to other organ
* problem with communication
* pregnancy
* body mass index \> 35 kg/m2
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jin Sun Cho, MD

Role: CONTACT

82-2-2228-5448

Facility Contacts

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Jin Sun Cho, MD

Role: primary

82-2-2228-5448

References

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Cho JS, Kim NY, Shim JK, Jun JH, Lee S, Kwak YL. The immunomodulatory effect of ketamine in colorectal cancer surgery: a randomized-controlled trial. Can J Anaesth. 2021 May;68(5):683-692. doi: 10.1007/s12630-021-01925-3. Epub 2021 Feb 2.

Reference Type DERIVED
PMID: 33532995 (View on PubMed)

Other Identifiers

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4-2017-0475

Identifier Type: -

Identifier Source: org_study_id

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